Repositionable heart valve

ABSTRACT

A replacement heart valve assembly including an expandable anchor having a skirt region, a lip region, and a groove region therebetween and a replacement valve disposed within the expandable anchor and engaged with the groove region of the expandable anchor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims priority to applicationof Ser. No. 14/490,000, filed Sep. 18, 2014, now U.S. Pat. No. 9,585,749which is a continuation of and claims priority to application of Ser.No. 10/746,280, filed Dec. 23, 2003, now U.S. Pat. No. 8,840,663, thecontents of which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION

The present invention relates to methods and apparatus forendovascularly replacing a heart valve. More particularly, the presentinvention relates to methods and apparatus for percutaneously replacinga heart valve with a replacement valve using an expandable andretrievable anchor.

Heart valve surgery is used to repair or replace diseased heart valves.Valve surgery is an open-heart procedure conducted under generalanesthesia. An incision is made through the patient's sternum(sternotomy), and the patient's heart is stopped while blood flow isrerouted through a heart-lung bypass machine.

Valve replacement may be indicated when there is a narrowing of thenative heart valve, commonly referred to as stenosis, or when the nativevalve leaks or regurgitates. When replacing the valve, the native valveis excised and replaced with either a biologic or a mechanical valve.Mechanical valves require lifelong anticoagulant medication to preventblood clot formation, and clicking of the valve often may be heardthrough the chest. Biologic tissue valves typically do not require suchmedication. Tissue valves may be obtained from cadavers or may beporcine or bovine, and are commonly attached to synthetic rings that aresecured to the patient's heart.

Valve replacement surgery is a highly invasive operation withsignificant concomitant risk. Risks include bleeding, infection, stroke,heart attack, arrhythmia, renal failure, adverse reactions to theanesthesia medications, as well as sudden death. 2-5% of patients dieduring surgery.

Post-surgery, patients temporarily may be confused due to emboli andother factors associated with the heart-lung machine. The first 2-3 daysfollowing surgery are spent in an intensive care unit where heartfunctions can be closely monitored. The average hospital stay is between1 to 2 weeks, with several more weeks to months required for completerecovery.

In recent years, advancements in minimally invasive surgery andinterventional cardiology have encouraged some investigators to pursuepercutaneous replacement of the aortic heart valve. Percutaneous ValveTechnologies (“PVT”) of Fort Lee, N.J., has developed aballoon-expandable stent integrated with a bioprosthetic valve. Thestent/valve device is deployed across the native diseased valve topermanently hold the valve open, thereby alleviating a need to excisethe native valve and to position the bioprosthetic valve in place of thenative valve. PVT's device is designed for delivery in a cardiaccatheterization laboratory under local anesthesia using fluoroscopicguidance, thereby avoiding general anesthesia and open-heart surgery.The device was first implanted in a patient in April of 2002.

PVT's device suffers from several drawbacks. Deployment of PVT's stentis not reversible, and the stent is not retrievable. This is a criticaldrawback because improper positioning too far up towards the aorta risksblocking the coronary ostia of the patient. Furthermore, a misplacedstent/valve in the other direction (away from the aorta, closer to theventricle) will impinge on the mitral apparatus and eventually wearthrough the leaflet as the leaflet continuously rubs against the edge ofthe stent/valve.

Another drawback of the PVT device is its relatively largecross-sectional delivery profile. The PVT system's stent/valvecombination is mounted onto a delivery balloon, making retrogradedelivery through the aorta challenging. An ante grade transseptalapproach may therefore be needed, requiring puncture of the septum androuting through the mitral valve, which significantly increasescomplexity and risk of the procedure. Very few cardiologists arecurrently trained in performing a transseptal puncture, which is achallenging procedure by itself.

Other prior art replacement heart valves use self-expanding stents asanchors. In the endovascular aortic valve replacement procedure,accurate placement of aortic valves relative to coronary ostia and themitral valve is critical. Standard self-expanding systems have very pooraccuracy in deployment, however. Often the proximal end of the stent isnot released from the delivery system until accurate placement isverified by fluoroscopy, and the stent typically jumps once released. Itis therefore often impossible to know where the ends of the stent willbe with respect to the native valve, the coronary ostia and the mitralvalve.

Also, visualization of the way the new valve is functioning prior tofinal deployment is very desirable. Visualization prior to final andirreversible deployment cannot be done with standard self-expandingsystems, however, and the replacement valve is often not fullyfunctional before final deployment.

Another drawback of prior art self-expanding replacement heart valvesystems is their lack of radial strength. In order for self-expandingsystems to be easily delivered through a delivery sheath, the metalneeds to flex and bend inside the delivery catheter without beingplastically deformed. In arterial stents, this is not a challenge, andthere are many commercial arterial stent systems that apply adequateradial force against the vessel wall and yet can collapse to a smallenough of a diameter to fit inside a delivery catheter withoutplastically deforming. However when the stent has a valve fastenedinside it, as is the case in aortic valve replacement, the anchoring ofthe stent to vessel walls is significantly challenged during diastole.The force to hold back arterial pressure and prevent blood from goingback inside the ventricle during diastole will be directly transferredto the stent/vessel wall interface. Therefore the amount of radial forcerequired to keep the self expanding stent/valve in contact with thevessel wall and not sliding will be much higher than in stents that donot have valves inside of them. Moreover, a self-expanding stent withoutsufficient radial force will end up dilating and contracting with eachheartbeat, thereby distorting the valve, affecting its function andpossibly migrating and dislodging completely. Simply increasing strutthickness of the self-expanding stent is not a practical solution as itruns the risk of larger profile and/or plastic deformation of theself-expanding stent.

U.S. patent application Serial No. 2002/0151970 to Garrison et al.describes a two-piece device for replacement of the aortic valve that isadapted for delivery through a patient's aorta. A stent ispercutaneously placed across the native valve, then a replacement valveis positioned within the lumen of the stent. By separating the stent andthe valve during delivery, a profile of the device's delivery system maybe sufficiently reduced to allow aortic delivery without requiring atransseptal approach. Both the stent and a frame of the replacementvalve may be balloon-expandable or self-expanding.

While providing for an aortic approach, devices described in theGarrison patent application suffer from several drawbacks. First, thestent portion of the device is delivered across the native valve as asingle piece in a single step, which precludes dynamic repositioning ofthe stent during delivery. Stent foreshortening or migration duringexpansion may lead to improper alignment.

Additionally, Garrison's stent simply crushes the native valve leafletsagainst the heart wall and does not engage the leaflets in a manner thatwould provide positive registration of the device relative to the nativeposition of the valve. This increases an immediate risk of blocking thecoronary ostia, as well as a longer-term risk of migration of the devicepost-implantation. Furtherstill, the stent comprises openings or gaps inwhich the replacement valve is seated post-delivery. Tissue may protrudethrough these gaps, thereby increasing a risk of improper seating of thevalve within the stent.

In view of drawbacks associated with previously known techniques forpercutaneously replacing a heart valve, it would be desirable to providemethods and apparatus that overcome those drawbacks.

SUMMARY OF THE INVENTION

One aspect of the invention provides a method for endovascularlyreplacing a heart valve of a patient. In some embodiments the methodincludes the steps of endovascularly delivering a replacement valve andan expandable anchor to a vicinity of the heart valve in an unexpandedconfiguration; expanding the anchor to a deployed configuration in whichthe anchor contacts tissue at an anchor site; repositioning the anchorin the anchor site; and deploying the anchor at the anchor site. Therepositioning step may include the step of contracting the anchor andre-expanding the anchor at the anchor site for finer repositioning. Thecontracting step may include the step of applying an externalnon-hydraulic or non-pneumatic actuation force on the anchor.

In another aspect of the invention provides a method for endovascularlyreplacing a heart valve of a patient. In some embodiments the methodincludes the steps of endovascularly or percutaneously delivering areplacement valve and an expandable anchor to a vicinity of the heartvalve in an unexpanded configuration; expanding the anchor to a deployedconfiguration in which the anchor contacts tissue at a first anchorsite; repositioning the anchor to a second anchor site; and deployingthe anchor at the second anchor site. The repositioning step may includethe step of contracting the anchor and reexpanding the anchor at thesecond anchor site. The contracting step may includes the step ofapplying an external non-hydraulic or non-pneumatic actuation force onthe anchor.

In some embodiments the deploying step includes the step of releasingthe anchor from a deployment tool. The delivering step may include thestep of delivering the replacement heart valve coupled to the anchor or,alternatively, separate from the anchor, in which case the methodfurther includes the step of attaching the replacement valve to theanchor.

In instances in which the heart valve is an aortic valve, the deliveringstep may include the step of endovascularly or percutaneously deliveringthe expandable anchor and replacement valve to the vicinity of theaortic valve along a retrograde approach.

In some embodiments the deploying step may include the step of expandinga balloon within the anchor, and in some embodiments the deploying stepmay include the step of locking the anchor in an expanded configuration.Proximal and distal regions of the anchor may be expanded separately.

The invention may also include the step of registering the anchor withthe first or second anchor site, such as by contacting tissue of theheart valve to resist movement of the anchor in at least a proximal or adistal direction prior to deploying the anchor.

Another aspect of the invention provides a method for percutaneouslyreplacing a heart valve of a patient. The method includes the steps ofpercutaneously delivering a replacement valve and an expandable anchorto a vicinity of the heart valve in an unexpanded configuration;expanding the anchor to an expanded configuration in which the anchorcontacts tissue at an anchor site, such as first a force of at least onepound; visually observing the anchor location; and releasing the anchorfrom a deployment tool. The replacement valve may be delivered coupledto the anchor or separate from the anchor, in which case the method alsoincludes the step of attaching the valve to the anchor.

In some embodiments the method further includes the step ofrepositioning the anchor to a second anchor site after the observingstep and before the releasing step. In some embodiments the expandingstep includes the step of applying an external non-hydraulic ornon-pneumatic actuation force on the anchor, and in some embodiments themethod further includes the step of expanding a balloon within theanchor after the observing step. The method may include the step ofregistering the anchor with the anchor site.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIGS. 1A-B are elevational views of a replacement heart valve and anchoraccording to one embodiment of the invention.

FIGS. 2A-B are sectional views of the anchor and valve of FIG. 1.

FIGS. 3A-D show delivery and deployment of a replacement heart valve and15 anchor, such as the anchor and valve of FIGS. 1 and 2.

FIGS. 4A-F also show delivery and deployment of a replacement heartvalve and anchor, such as the anchor and valve of FIGS. 1 and 2.

FIGS. 5A-F show the use of a replacement heart valve and anchor toreplace an aortic valve.

FIGS. 6A-F show the use of a replacement heart valve and anchor with apositive registration feature to replace an aortic valve.

FIG. 7 shows the use of a replacement heart valve and anchor with analternative positive registration feature to replace an aortic valve.

FIGS. 8A-C show another embodiment of a replacement heart valve andanchor according to the invention.

FIGS. 9A-H show delivery and deployment of the replacement heart valveand anchor of FIG. 8.

FIG. 10 is a cross-sectional drawing of the delivery system used withthe method and apparatus of FIGS. 8 and 9.

FIGS. 11A-C show alternative locks for use with replacement heart valvesand anchors of this invention.

FIGS. 12A-C show a vessel wall engaging lock for use with replacementheart valves and anchors of this invention.

FIG. 13 demonstrates paravalvular leaking around a replacement heartvalve and anchor.

FIG. 14 shows a seal for use with a replacement heart valve and anchorof this invention.

FIGS. 15A-E show alternative arrangements of seals on a replacementheart valve and anchor.

FIGS. 16A-F show alternative seal designs for use with replacement heartvalves and anchors.

FIGS. 17A-B show an alternative anchor lock embodiment in an unlockedconfiguration.

FIG. 18A-B shows the anchor lock of FIGS. 17A-B in a lockedconfiguration.

FIG. 19 shows an alternative anchor deployment tool attachment andrelease mechanism for use with the invention.

FIG. 20 shows the attachment and release mechanism of FIG. 19 in theprocess of being released.

FIG. 21 shows the attachment and release mechanism of FIGS. 19 and 20 ina released condition.

FIG. 22 shows an alternative embodiment of a replacement heart valve andanchor and a deployment tool according to the invention in an undeployedconfiguration.

FIG. 23 shows the replacement heart valve and anchor of FIG. 22 in apartially deployed configuration.

FIG. 24 shows the replacement heart valve and anchor of FIGS. 22 and 23in a more fully deployed configuration but with the deployment toolstill attached.

FIG. 25 shows yet another embodiment of the delivery and deploymentapparatus of the invention in use with a replacement heart valve andanchor.

FIG. 26 shows the delivery and deployment apparatus of FIG. 25 in theprocess of deploying a replacement heart valve and anchor.

FIG. 27 show an embodiment of the invention employing seals at theinterface of the replacement heart valve and anchor and the patient'stissue.

FIG. 28 is a longitudinal cross-sectional view of the seal shown in FIG.27 in compressed form.

FIG. 29 is a transverse cross-sectional view of the seal shown in FIG.28.

FIG. 30 is a longitudinal cross-sectional view of the seal shown in FIG.27 in expanded form.

FIG. 31 is a transverse cross-sectional view of the seal shown in FIG.30.

FIG. 32 shows yet another embodiment of the replacement heart valve andanchor of this invention in an undeployed configuration.

FIG. 33 shows the replacement heart valve and anchor of FIG. 32 in adeployed configuration.

FIG. 34 shows the replacement heart valve and anchor of FIGS. 32 and 33deployed in a patient's heart valve.

FIGS. 35A-H show yet another embodiment of a replacement heart valve,anchor and deployment system according to this invention.

FIGS. 36A-E show more detail of the anchor of the embodiment shown inFIGS. 35A-H.

FIGS. 37A-B show other embodiments of the replacement heart valve andanchor of the invention.

FIGS. 38A-C illustrate a method for percutaneously replacing a patient'sdiseased heart valve.

FIGS. 39A-B show an anchor for use in a two-piece replacement heartvalve and anchor embodiment of the invention.

FIGS. 40A-B show a replacement heart valve for use in a two-piecereplacement heart valve and anchor embodiment of the invention.

FIGS. 41A-D show a method of coupling the anchor of FIG. 39 and thereplacement heart valve of FIG. 40.

FIG. 42 shows a delivery system for use with the apparatus shown inFIGS. 39-41.

FIG. 43 shows an alternative embodiment of a delivery system for usewith the apparatus shown in FIGS. 39-41.

FIG. 44 shows yet another alternative embodiment of a delivery systemfor use with the apparatus shown in FIGS. 39-41.

FIGS. 45A-I illustrate a method of delivering and deploying a two-piecereplacement heart valve and anchor.

FIGS. 46A-B shows another embodiment of a two-piece replacement heartvalve and anchor according to this invention.

FIG. 47 shows yet another embodiment of a two-piece replacement heartvalve and anchor according to this invention.

FIG. 48 shows yet another embodiment of a two-piece replacement heartvalve and anchor according to this invention.

DETAILED DESCRIPTION OF THE INVENTION

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

With reference now to FIGS. 1-4, a first embodiment of replacement heartvalve apparatus in accordance with the present invention is described,including a method of actively foreshortening and expanding theapparatus from a delivery configuration and to a deployed configuration.Apparatus 10 comprises replacement valve 20 disposed within and coupledto anchor 30. FIG. 1 schematically illustrate individual cells of anchor30 of apparatus 10, and should be viewed as if the cylindrical anchorhas been cut open and laid flat. FIG. 2 schematically illustrate adetail portion of apparatus 10 in side-section.

Anchor 30 has a lip region 32, a skirt region 34 and a body region 36.First, second and third posts 38 a, 38 b and 38 c, respectively, arecoupled to skirt region 34 and extend within lumen 31 of anchor 30.Posts 38 preferably are spaced 120° apart from one another about thecircumference of anchor 30.

Anchor 30 preferably is fabricated by using self-expanding patterns(laser cut or chemically milled), braids and materials, such as astainless steel, nickel-titanium (“Nitinol”) or cobalt chromium butalternatively may be fabricated using balloon-expandable patterns wherethe anchor is designed to plastically deform to it's final shape bymeans of balloon expansion. Replacement valve 20 is preferably frombiologic tissues, e.g. porcine valve leaflets or bovine or equinepericardium tissues, alternatively it can be made from tissue engineeredmaterials (such as extracellular matrix material from Small IntestinalSubmucosa (SIS)) but alternatively may be prosthetic from an elastomericpolymer or silicone, Nitinol or stainless steel mesh or pattern(sputtered, chemically milled or laser cut). The leaflet may also bemade of a composite of the elastomeric or silicone materials and metalalloys or other fibers such Kevlar or carbon. Annular base 22 ofreplacement valve 20 preferably is coupled to skirt region 34 of anchor30, while commissures 24 of replacement valve leaflets 26 are coupled toposts 38.

Anchor 30 may be actuated using external non-hydraulic or non-pneumaticforce to actively foreshorten in order to increase its radial strength.As shown below, the proximal and distal end regions of anchor 30 may beactuated independently. The anchor and valve may be placed and expandedin order to visualize their location with respect to the native valveand other anatomical features and to visualize operation of the valve.The anchor and valve may thereafter be repositioned and even retrievedinto the delivery sheath or catheter. The apparatus may be delivered tothe vicinity of the patient's aortic valve in a retrograde approach in acatheter having a diameter no more than 23 french, preferably no morethan 21 french, more preferably no more than 19 french, or morepreferably no more than 17 french. Upon deployment the anchor andreplacement valve capture the native valve leaflets and positively lockto maintain configuration and position.

A deployment tool is used to actuate, reposition, lock and/or retrieveanchor 30. In order to avoid delivery of anchor 30 on a balloon forballoon expansion, a non-hydraulic or non-pneumatic anchor actuator isused. In this embodiment, the actuator is a deployment tool thatincludes distal region control wires 50, control rods or tubes 60 andproximal region control wires 62. Locks 40 include posts or arms 38preferably with male interlocking elements 44 extending from skirtregion 34 and mating female interlocking elements 42 in lip region 32.Male interlocking elements 44 have eyelets 45. Control wires 50 passfrom a delivery system for apparatus 10 through female interlockingelements 42, through eyelets 45 of male interlocking elements 44, andback through female interlocking elements 42, such that a double strandof wire 50 passes through each female interlocking element 42 formanipulation by a medical practitioner external to the patient toactuate and control the anchor by changing the anchor's shape. Controlwires 50 may comprise, for example, strands of suture.

Tubes 60 are reversibly coupled to apparatus 10 and may be used inconjunction with wires 50 to actuate anchor 30, e.g., to foreshorten andlock apparatus 10 in the fully deployed configuration. Tubes 60 alsofacilitate repositioning and retrieval of apparatus 10, as describedhereinafter. For example, anchor 30 may be foreshortened and radiallyexpanded by applying a distally directed force on tubes 60 whileproximally retracting wires 50. As seen in FIG. 3, control wires 62 passthrough interior lumens 61 of tubes 60. This ensures that tubes 60 arealigned properly with apparatus 10 during deployment and foreshortening.Control wires 62 can also actuate anchor 60; proximally directed forceson control wires 62 contacts the proximal lip region 32 of anchor 30.Wires 62 also act to couple and decouple tubes 60 from apparatus 10.Wires 62 may comprise, for example, strands of suture.

FIGS. 1A and 2A illustrate anchor 30 in a delivery configuration or in apartially deployed configuration (e.g., after dynamic self-expansionexpansion from a constrained delivery configuration within a deliverysheath). Anchor 30 has a relatively long length and a relatively smallwidth in the delivery or partially deployed configuration, as comparedto the foreshortened and fully deployed configuration of FIGS. 1B and2B.

In FIGS. 1A and 2A, replacement valve 20 is collapsed within lumen 31 ofanchor 30. Retraction of wires 50 relative to tubes 60 foreshortensanchor 30, which increases the anchor's width while decreasing itslength. Such foreshortening also properly seats replacement valve 20within lumen 31 of anchor 30. Imposed foreshortening will enhance radialforce applied by apparatus 10 to surrounding tissue over at least aportion of anchor 30. In some embodiments, the anchor exerts an outwardforce on surrounding tissue to engage the tissue in such way to preventmigration of anchor caused by force of blood against closed leafletduring diastole. This anchoring force is preferably 1 to 2 lbs, morepreferably 2 to 4 lbs, or more preferably 4 to 10 lbs. In someembodiments, the anchoring force is preferably greater than 1 pound,more preferably greater than 2 pounds, or more preferably greater than 4pounds. Enhanced radial force of the anchor is also important forenhanced crush resistance of the anchor against the surrounding tissuedue to the healing response (fibrosis and contraction of annulus over alonger period of time) or to dynamic changes of pressure and flow ateach heart beat In an alternative embodiment, the anchor pattern orbraid is designed to have gaps or areas where the native tissue isallowed to protrude through the anchor slightly (not shown) and as theforeshortening is applied, the tissue is trapped in the anchor. Thisfeature would provide additional means to prevent anchor migration andenhance long term stability of the device.

Deployment of apparatus 10 is fully reversible until lock 40 has beenlocked via mating of male interlocking elements 44 with femaleinterlocking elements 42. Deployment is then completed by decouplingtubes 60 from lip section 32 of anchor 30 by retracting one end of eachwire 62 relative to the other end of the wire, and by retracting one endof each wire 50 relative to the other end of the wire until each wirehas been removed from eyelet 45 of its corresponding male interlockingelement 44.

As best seen in FIG. 2B, body region 36 of anchor 30 optionally maycomprise barb elements 37 that protrude from anchor 30 in the fullydeployed configuration, for example, for engagement of a patient'snative valve leaflets and to preclude migration of the apparatus.

With reference now to FIG. 3, a delivery and deployment system for aself-expanding embodiment of apparatus 10 including a sheath 110 havinga lumen 112. Self-expanding anchor 30 is collapsible to a deliveryconfiguration within lumen 112 of sheath 110,such that apparatus 10 maybe delivered via delivery system 100. As seen in FIG. 3A,apparatus 10may be deployed from lumen 112 by retracting sheath 110 relative toapparatus 10,control wires 50 and tubes 60, which causes anchor 30 todynamically self-expand to a partially deployed configuration as seen inthe partial side view of FIG. 3C. Control wires 50 then are retractedrelative to apparatus 10 and tubes 60 to impose foreshortening uponanchor 30, as seen in FIG. 3B. As seen in the partial side views ofFIGS. 3D and 3E, the foreshortening is accompanied by local folding.

During foreshortening, tubes 60 push against lip region 32 of anchor 30,while wires 50 pull on posts 38 of the anchor. Wires 62 may be retractedalong with wires 50 to enhance the distally-directed pushing forceapplied by tubes 60 to lip region 32. Continued retraction of wires 50relative to tubes 60 would lock locks 40 and fully deploy apparatus 10with replacement valve 20 properly seated within anchor 30, as in FIGS.1B and 2B. Apparatus 10 comprises enhanced radial strength in the fullydeployed configuration as compared to the partially deployedconfiguration of FIG. 3A. Once apparatus 10 has been fully deployed,wires 50 and 62 may be removed from apparatus 10, thereby separatingdelivery system 100 and tubes 60 from the apparatus.

Deployment of apparatus 10 is fully reversible until locks 40 have beenactuated. For example, just prior to locking the position of the anchorand valve and the operation of the valve may be observed underfluoroscopy. If the position needs to be changed, by alternatelyrelaxing and reapplying the proximally directed forces exerted bycontrol wires 50 and/or control wires 62 and the distally directedforces exerted by tubes 60, expansion and contraction of the lip andskirt regions of anchor 30 may be independently controlled so that theanchor and valve can be moved to, e.g., avoid blocking the coronaryostia or impinging on the mitral valve. Apparatus 10 may also becompletely retrieved within lumen 112 of sheath 110 by simultaneouslyproximally retracting wires 50 and tubes 60/wires 62 relative to sheath110. Apparatus 10 then may be removed from the patient or repositionedfor subsequent redeployment.

Referring now to FIG. 4, step-by-step deployment of apparatus 10 viadelivery system 100 is described. In FIG. 4A, sheath 110 is retractedrelative to apparatus 10, wires 50 and tubes 60, thereby causingself-expandable anchor 30 to dynamically self-expand apparatus 10 fromthe collapsed delivery configuration within lumen 112 of sheath 110 tothe partially deployed configuration. Apparatus 10 may then bedynamically repositioned via tubes 60 to properly orient the apparatus,e.g. relative to a patient's native valve leaflets.

In FIG. 4B, control wires 50 are retracted while tubes 60 are advanced,thereby urging lip region 32 of anchor 30 in a distal direction whileurging posts 38 of the anchor in a proximal direction. This foreshortensapparatus 10, as seen in FIG. 4C. Deployment of apparatus 10 is fullyreversible even after: foreshortening has been initiated and hasadvanced to the point illustrated in FIG. 4C.

In FIG. 4D, continued foreshortening causes male interlocking elements44 of locks 40 to engage female interlocking elements 42. The maleelements mate with the female elements, thereby locking apparatus 10 inthe foreshortened configuration, as seen in FIG. 4E. Wires 50 are thenpulled through eyelets 45 of male elements 44 to remove the wires fromapparatus 10, and wires 62 are pulled through the proximal end of anchor30 to uncouple tubes 60 from the apparatus, thereby separating deliverysystem 100 from apparatus 10. Fully deployed apparatus 10 is shown inFIG. 4F.

Referring to FIG. 5, a method of percutaneously replacing a patient'sdiseased aortic valve with apparatus 10 and delivery system 100 isdescribed. As seen in Figure SA, sheath 110 of delivery system 100,having apparatus 10 disposed therein, is percutaneously advanced overguide wire G, preferably in a retrograde fashion (although an antegradeor hybrid approach alternatively may be used), through a patient's aortaA to the patient's diseased aortic valve AV. A nosecone 102 precedessheath 110 in a known manner. In FIG. 5B, sheath 11.0 is positioned suchthat its distal region is disposed within left ventricle LV of thepatient's heart H.

Apparatus 10 is deployed from lumen 112 of sheath 110, for example,under fluoroscopic guidance, such that anchor 30 of apparatus 10dynamically self-expands to a partially deployed configuration, as inFIG. 5C. Advantageously, apparatus 10 may be retracted within lumen 112of sheath 110 via wires 50—even after anchor 30 has dynamically expandedto the partially deployed configuration, for example, to abort theprocedure or to reposition apparatus 10 or delivery system 100. As yetanother advantage, apparatus 10 may be dynamically repositioned, e.g.via sheath 110 and/or tubes 60, in order to properly align the apparatusrelative to anatomical landmarks, such as the patient's coronary ostiaor the patient's native valve leaflets L. When properly aligned, skirtregion 34 of anchor 30 preferably is disposed distal of the leaflets,while body region 36 is disposed across the leaflets and lip region 32is disposed proximal of the leaflets.

Once properly aligned, wires 50 are retracted relative to tubes 60 toimpose foreshortening upon anchor 30 and expand apparatus 10 to thefully deployed configuration, as in FIG. 5D. Foreshortening increasesthe radial strength of anchor 30 to ensure prolonged patency of valveannulus An, as well as to provide a better seal for apparatus 10 thatreduces paravalvular regurgitation. As seen in FIG. 5E, locks 40maintain imposed foreshortening. Replacement valve 20 is properly seatedwithin anchor 30, and normal blood flow between left ventricle LV andaorta A is thereafter regulated by apparatus 10. Deployment of apparatus10 advantageously is fully reversible until locks 40 have been actuated.

As seen in FIG. 5F, wires 50 are pulled from eyelets 45 of male elements44 of locks 40, tubes 60 are decoupled from anchor 30, e.g. via wires62, and delivery system 100 is removed from the patient, therebycompleting deployment of apparatus 10. Optional barb elements 37 engagethe patient's native valve leaflets, e.g. to preclude migration of theapparatus and/or reduce paravalvular regurgitation.

With reference now to FIG. 6, a method of percutaneously replacing apatient's diseased aortic valve with apparatus 10 is provided, whereinproper positioning of the apparatus is ensured via positive registrationof a modified delivery system to the patient's native valve leaflets. InFIG. 6A, modified delivery system 100′ delivers apparatus 10 to diseasedaortic valve A V within sheath 110. As seen in FIGS. 6B and 6C,apparatus 10 is deployed from lumen 112 of sheath 110, for example,under fluoroscopic guidance, such that anchor 30 of apparatus 10dynamically self-expands to a partially deployed configuration. As whendeployed via delivery system 100, deployment of apparatus 10 viadelivery system 100′ is fully reversible until locks 40 have beenactuated.

Delivery system 100′ comprises leaflet engagement element 120, whichpreferably self-expands along with anchor 30. Engagement element 120 isdisposed between tubes 60 of delivery system 100′ and lip region 32 ofanchor 30. Element 120 releasably engages the anchor. As seen in FIG.6C, the element is initially deployed proximal of the patient's nativevalve leaflets L. Apparatus 10 and element 120 then may beadvanced/dynamically repositioned until engagement element positivelyregisters against the leaflets, thereby ensuring proper positioning ofapparatus 10. Also delivery system 100′ includes filter structure 61A(e.g., filter membrane or braid) as part of push tubes 60 to act as anembolic protection element. Emboli can be generated during manipulationand placement of anchor from either diseased native leaflet orsurrounding aortic tissue and can cause blockage. Arrows 61B in FIG. 6Eshow blood flow through filter structure 61A where blood is allowed toflow but emboli is trapped in the delivery system and removed with it atthe end of the procedure.

Alternatively, foreshortening may be imposed upon anchor 30 whileelement 120 is disposed proximal of the leaflets, as in FIG. 6D. Uponpositive registration of element 120 against leaflets L, element 120precludes further distal migration of apparatus 10 during additionalforeshortening, thereby reducing a risk of improperly positioning theapparatus. FIG. 6E details engagement of element 120 against the nativeleaflets. As seen in FIG. 6F, once apparatus 10 is fully deployed,element 120, wires 50 and tubes 60 are decoupled from the apparatus, anddelivery system 100′ is removed from the patient, thereby completing theprocedure.

With reference to FIG. 7, an alternative embodiment of the apparatus ofFIG. 6 is described, wherein leaflet engagement element 120 is coupledto anchor 30 of apparatus 10′, rather than to delivery system 100.Engagement element 120 remains implanted in the patient post-deploymentof apparatus 10′. Leaflets L are sandwiched between lip region 32 ofanchor 30 and element 120 in the fully deployed configuration. In thismanner, element 120 positively registers apparatus 10′ relative to theleaflets and precludes distal migration of the apparatus over time.

Referring now to FIG. 8, an alternative delivery system adapted for usewith a balloon expandable embodiment of the present invention isdescribed. In FIG. 8A, apparatus 10″ comprises anchor 30′ that may befabricated from balloon-expandable materials. Delivery system 1 00″comprises inflatable member 130 disposed in a deflated configurationwithin lumen 31 of anchor 30′. In FIG. 8B, optional outer sheath 110 isretracted, and inflatable member 130 is inflated to expand anchor 30′ tothe fully deployed configuration. As inflatable member 130 is beingdeflated, as in earlier embodiments, wires 50 and 62 and tubes 60 may beused to assist deployment of anchor 30′ and actuation of locks 40, aswell as to provide reversibility and retrievability of apparatus 10″prior to actuation of locks 40. Next, wires 50 and 62 and tubes 60 areremoved from apparatus 10″, and delivery system 100″ is removed, as seenin Figure SC.

As an alternative delivery method, anchor 30′ may be partially deployedvia partial expansion of inflatable member 130. The inflatable memberwould then be advanced within replacement valve 20 prior to inflation ofinflatable member 130 and full deployment of apparatus 10″. Inflationpressures used will range from about 3 to 6 atm, or more preferably fromabout 4 to 5 atm, though higher and lower atm pressures may also be used(e.g., greater than 3 atm, more preferably greater than 4 atm, morepreferably greater than 5 atm, or more preferably greater than 6 atm).Advantageously, separation of inflatable member 130 from replacementvalve 20, until partial deployment of apparatus 10″ at a treatment site,is expected to reduce a delivery profile of the apparatus, as comparedto previously known apparatus. This profile reduction may facilitateretrograde delivery and deployment of apparatus 10″, even when anchor30′ is balloon-expandable.

Although anchor 30′ has illustratively been described as fabricated fromballoon-expandable materials, it should be understood that anchor 30′alternatively may be fabricated from self-expanding materials whoseexpansion optionally may be balloon-assisted. In such a configuration,anchor 30′ would expand to a partially deployed configuration uponremoval of outer sheath 110. If required, inflatable member 130 thenwould be advanced within replacement valve 20 prior to inflation.Inflatable member 130 would assist full deployment of apparatus 10″, forexample, when the radial force required to overcome resistance fromimpinging tissue were too great to be overcome simply by manipulation ofwires 50 and tubes 60. Advantageously, optional placement of inflatablemember 130 within replacement valve 20, only after dynamicself-expansion of apparatus 10″ to the partially deployed configurationat a treatment site, is expected to reduce a delivery profile of theapparatus, as compared to previously known apparatus. This reduction mayfacilitate retrograde delivery and deployment of apparatus 10″.

With reference to FIGS. 9 and 10, methods and apparatus for aballoon-assisted embodiment of the present invention are described ingreater detail. FIGS. 9 and 10 illustratively show apparatus 10′ of FIG.7 used in combination with delivery system 100″ of FIG. 8. FIG. 10illustrates a sectional view of delivery system 100″. Inner shaft 132 ofinflatable member 130 preferably is about 4 Fr in diameter, andcomprises lumen 133 configured for passage of guidewire G, having adiameter of about 0.035″, therethrough. Push tubes 60 and pull wires 50pass through guidetube 140, which preferably has a diameter of about 15Fr or smaller. Guide tube 140 is disposed within lumen 112 of outersheath 110, which preferably has a diameter of about 17 Fr or smaller.

In FIG. 9A, apparatus 10′ is delivered to diseased aortic valve AVwithin lumen 112 of sheath 110. In FIG. 9B, sheath 110 is retractedrelative to apparatus 10′ to dynamically self-expand the apparatus tothe partially deployed configuration. Also retracted and removed isnosecone 102 which is attached to a pre-slit lumen (not shown) thatfacilitates its removal prior to loading an advancing of a regularangioplasty balloon catheter over guidewire and inside delivery system110.

In FIG. 9C, pull wires 50 and push tubes 60 are manipulated fromexternal to the patient to foreshorten anchor 30 and sufficiently expandlumen 31 of the anchor to facilitate advancement of inflatable member130 within replacement valve 20. Also shown is the tip of an angioplastycatheter 130 being advanced through delivery system 110.

The angioplasty balloon catheter or inflatable member 130 then isadvanced within the replacement valve, as in FIG. 9D, and additionalforeshortening is imposed upon anchor 30 to actuate locks 40, as in FIG.9E. The inflatable member is inflated to further displace the patient'snative valve leaflets Land ensure adequate blood flow through, andlong-term patency of, replacement valve 20, as in FIG. 9F. Inflatablemember 130 then is deflated and removed from the patient, as in FIG. 9G.A different size angioplasty balloon catheter could be used to repeatthe same step if deemed necessary by the user. Push tubes 60 optionallymay be used to further set leaflet engagement element 120, or optionalbarbs B along posts 38, more deeply within leaflets L, as in FIG. 9H.Then, delivery system 100″ is removed from the patient, therebycompleting percutaneous heart valve replacement.

As will be apparent to those of skill in the art, the order of imposedforeshortening and balloon expansion described in FIGS. 9 and 10 is onlyprovided for the sake of illustration. The actual order may varyaccording to the needs of a given patient and/or the preferences of agiven medical practitioner. Furthermore, balloon-assist may not berequired in all instances, and the inflatable member may act merely as asafety precaution employed selectively in challenging clinical cases.

Referring now to FIG. 11, alternative locks for use with apparatus ofthe present invention are described. In FIG. 11A, lock 40′ comprisesmale interlocking element 44 as described previously. However, femaleinterlocking element 42′ illustratively comprises a triangular shape, ascompared to the round shape of interlocking element 42 describedpreviously. The triangular shape of female interlocking element 42′ mayfacilitate mating of male interlocking element 44 with the femaleinterlocking element without necessitating deformation of the maleinterlocking element.

In FIG. 11B, lock 40″ comprises alternative male interlocking element44′ having multiple in-line arrowheads 46 along posts 38. Each arrowheadcomprises resiliently deformable appendages 48 to facilitate passagethrough female interlocking element 42. Appendages 48 optionallycomprise eyelets 49, such that control wire 50 or a secondary wire maypass therethrough to constrain the appendages in the deformedconfiguration. To actuate lock 40″, one or more arrowheads 46 of maleinterlocking element 44′ are drawn through female interlocking element42, and the wire is removed from eyelets 49, thereby causing appendages48 to resiliently expand and actuate lock 40″.

Advantageously, providing multiple arrowheads 46 along posts 38 yields aratchet that facilitates in-vivo determination of a degree offoreshortening imposed upon apparatus of the present invention.Furthermore, optionally constraining appendages 48 of arrowheads 46 viaeyelets 49 prevents actuation of lock 40″ (and thus deployment ofapparatus of the present invention) even after male element 44′ has beenadvanced through female element 42. Only after a medical practitionerhas removed the wire constraining appendages 48 is lock 40″ fullyengaged and deployment no longer reversible.

Lock 40″′ of FIG. 11C is similar to lock 40″ of FIG. 11B, except thatoptional eyelets 49 on appendages 48 have been replaced by optionalovertube 47. Overtube 47 serves a similar function to eyelets 49 byconstraining appendages 48 to prevent locking until a medicalpractitioner has determined that apparatus of the present invention hasbeen foreshortened and positioned adequately at a treatment site.Overtube 47 is then removed, which causes the appendages to resilientlyexpand, thereby fully actuating lock 40″′.

With reference to FIG. 12, an alternative locking mechanism is describedthat is configured to engage the patient's aorta. Male interlockingelements 44″ of locks 40″″ comprise arrowheads 46′ having sharpenedappendages 48′. Upon expansion from the delivery configuration of FIG.12A to the foreshortened configuration of FIG. 12B, apparatus 10positions sharpened appendages 48′ adjacent the patient's aorta A.Appendages 48′ engage the aortic wall and reduce a risk of devicemigration over time.

With reference now to FIG. 13, a risk of paravalvular leakage orregurgitation around apparatus of the present invention is described. InFIG. 13, apparatus 10 has been implanted at the site of diseased aorticvalve AV, for example, using techniques described hereinabove. Thesurface of native valve leaflets L is irregular, and interface I betweenleaflets L and anchor 30 may comprise gaps where blood B may seepthrough. Such leakage poses a risk of blood clot formation orinsufficient blood flow.

Referring to FIG. 14, optional elements for reducing regurgitation orleakage are described. Compliant sacs 200 may be disposed about theexterior of anchor 30 to provide a more efficient seal along irregularinterface I. Sacs 200 may be filled with an appropriate material, forexample, water, blood, foam or a hydrogel. Alternative fill materialswill be apparent.

With reference to FIG. 15, illustrative arrangements for sacs 200 areprovided. In FIG. 15A, sacs 200 are provided as discrete sacs atdifferent positions along the height of anchor 30. In FIG. 15B, the sacsare provided as continuous cylinders at various heights. In FIG. 15C, asingle sac is provided with a cylindrical shape that spans multipleheights. The sacs of FIG. 15D are discrete, smaller and provided inlarger quantities. FIG. 15E provides a spiral sac. Alternative sacconfigurations will be apparent to those of skill in the art.

FIG. 16A, sacs 20 comprise ‘fish-scale’ slots 202 that may beback-filled, for example, with ambient blood passing through replacementvalve 20. In FIG. 16B, the sacs comprise pores 204 that may be used tofill the sacs. In FIG. 16C, the sacs open to lumen 31 of anchor 30 andare filled by blood washing past the sacs as the blood moves throughapparatus 10, as may be seen in the respective partial side view ofFIGS. 16D-16F.

FIGS. 17A-B and 18A-B show yet another alternative embodiment of theanchor lock. Anchor 300 has a plurality of male interlocking elements302 having eyelets 304 formed therein. Male interlocking elements areconnected to braided structure 300 by inter-weaving elements 302 (and308) or alternatively suturing, soldering, welding, or connecting withadhesive. Valve commissures 24 are connected to male interlockingelements 302 along their length. Replacement valve 20 annular base 22 isconnected to the distal end 34 of anchor 300 (or 30) as is illustratedin FIGS. 1A and 1B. Male interlocking elements 302 also include holes306 that mate with tabs 310 extending into holes 312 in femaleinterlocking elements 308. T6 lock, control wires 314 passing througheyelets 304 and holes 312 are pulled proximally with respect to theproximal end of braided anchor 300 to draw the male interlockingelements through holes 312 so that tabs 310 engage holes 306 in maleinterlocking elements 302. Also shown is release wires 314B that passesthrough eyelet 304B in female interlocking element 308. If needed,during the procedure, the user may pull on release wires 314B reversingorientation of tabs 310 releasing the anchor and allowing forrepositioning of the device or it's removal from the patient. Only whenfinal positioning as desired by the operating physician, would releasewire 314B and control wire 314 are cut and removed from the patient withthe delivery system.

FIGS. 19-21 show an alternative way of releasing the connection betweenthe anchor and its actuating tubes and control wires. Control wires 62extend through tubes 60 from outside the patient, loop through theproximal region of anchor 30 and extend partially back into tube 60. Thedoubled up portion of control wire 62 creates a force fit within tube 60that maintains the control wire's position with respect to tube 60 whenall control wires 62 are pulled proximally to place a proximallydirected force on anchor 30. When a single control wire 62 is pulledproximally, however, the frictional fit between that control wire andthe tube in which it is disposed is overcome, enabling the end 63 ofcontrol wire 62 to pull free of the tube, as shown in FIG. 21, therebyreleasing anchor 30.

FIGS. 22-24 show an alternative embodiment of the anchor. Anchor 350 ismade of a metal braid, such as Nitinol or stainless steel. A replacementvalve 354 is disposed within anchor 350. Anchor 350 is actuated insubstantially the same way as anchor 30 of FIGS. 1-4 through theapplication of proximally and distally directed forces from controlwires (not shown) and tubes 352.

FIGS. 25 and 26 show yet another embodiment of the delivery anddeployment apparatus of the invention. As an alternative to the balloonexpansion method described with respect to FIG. 8, in this embodimentthe nosecone (e.g., element 102 of FIG. 5) is replaced by an angioplastyballoon catheter 360. Thus, expandable balloon catheter 360 recedessheath 110 on guidewire G. When anchor 30 and valve 20 are expandedthrough the operation of tubes 60 and the control wires (not shown) asdescribed above, balloon catheter 360 is retracted proximally within theexpanded anchor and valve and expanded further as described above withrespect to FIG. 8.

FIGS. 27-31 show seals 370 that expand over time to seal the interfacebetween the anchor and valve and the patient's tissue. Seals 370 arepreferably formed from Nitinol wire surrounded by an expandable foam. Asshown in cross-section in FIGS. 28 and 29, at the time of deployment,the foam 372 is compressed about the wire 374 and held in the compressedform by a time-released coating 376. After deployment, coating 376dissolves in vivo to allow foam 372 to expand, as shown in FIGS. 30 and31.

FIGS. 32-34 show another way to seal the replacement valve againstleakage. A fabric seal 380 extends from the distal end of valve 20 andback proximally over anchor 30 during delivery. When deployed, as shownin FIGS. 33 and 34, fabric seal 380 bunches up to create fabric flapsand pockets that extend into spaces formed by the native valve leaflets382, particularly when the pockets are filled with blood in response tobackflow blood pressure. This arrangement creates a seal around thereplacement valve.

FIGS. 35A-H show another embodiment of a replacement heart valveapparatus in accordance with the present invention. Apparatus 450comprises replacement valve 460 (see FIGS. 37B and 38C) disposed withinand coupled to anchor 470. Replacement valve 460 is preferably biologic,e.g. porcine, but alternatively may be synthetic. Anchor 470 preferablyis fabricated from self-expanding materials, such as a stainless steelwire mesh or a nickel-titanium alloy (“Nitinol”), and comprises lipregion 472, skirt region 474, and body regions 476 a, 476 b and 476 c.Replacement valve 460 preferably is coupled to skirt region 474, butalternatively maybe coupled to other regions of the anchor. As describedhereinbelow, lip region 472 and skirt region 474 are configured toexpand and engage/capture a patient's native valve leaflets, therebyproviding positive registration, reducing paravalvular regurgitation,reducing device migration, etc.

As seen in FIG. 35A, apparatus 450 is collapsible to a deliveryconfiguration, wherein the apparatus may be delivered via deliverysystem 410. Delivery system 410 comprises sheath 420 having lumen 422,as well as wires 424 a and 424 b seen in FIGS. 35D-35G. Wires 424 a areconfigured to expand skirt region 474 of anchor 470, as well asreplacement valve 460 coupled thereto, while wires 424 b are configuredto expand lip region 472.

As seen in FIG. 35B, apparatus 450 may be delivered and deployed fromlumen 422 of catheter 420 while the apparatus is disposed in thecollapsed delivery configuration. As seen in FIGS. 35B-35D, catheter 420is retracted relative to apparatus 450, which causes anchor 470 todynamically self-expand to a partially deployed configuration. Wires 424a are then retracted to expand skirt region 474, as seen in FIGS. 35Eand 35F. Preferably, such expansion may be maintained via lockingfeatures described hereinafter.

In FIG. 35G, wires 424 b are retracted to expand lip region 472 andfully deploy apparatus 450. As with skirt region 474, expansion of lipregion 472 preferably may be maintained via locking features. After bothlip region 472 and skirt region 474 have been expanded, wires 424 may beremoved from apparatus 450, thereby separating delivery system 410 fromthe apparatus. Delivery system 410 then may be removed, as seen in FIG.35H.

As will be apparent to those of skill in the art, lip region 472optionally may be expanded prior to expansion of skirt region 474. Asyet another alternative, lip region 472 and skirt region 474 optionallymay be expanded simultaneously, in parallel, in a step-wise fashion orsequentially. Advantageously, delivery of apparatus 450 is fullyreversible until lip region 472 or skirt region 474 has been locked inthe expanded configuration.

With reference now to FIGS. 36A-E, individual cells of anchor 470 ofapparatus 450 are described to detail deployment and expansion of theapparatus. In FIG. 36A, individual cells of lip region 472, skirt region474 and body regions 476 a, 476 b and 476 c are shown in the collapseddelivery configuration, as they would appear while disposed within lumen422 of sheath 420 of delivery system 410 of FIG. 35. A portion of thecells forming body regions 476, for example, every ‘nth’ row of cells,comprises locking features.

Body region 476 a comprises male interlocking element 482 of lip lock480, while body region 476 b comprises female interlocking element 484of lip lock 480. Male element 482 comprises eyelet 483. Wire 424 bpasses from female interlocking element 484 through eyelet 483 and backthrough female interlocking element 484, such that there is a doublestrand of wire 424 b that passes through lumen 422 of catheter 420 formanipulation by a medical practitioner external to the patient. Bodyregion 476 b further comprises male interlocking element 492 of skirtlock 490, while body region 476 c comprises female interlocking element494 of the skirt lock. Wire 424 a passes from female interlockingelement 494 through eyelet 493 of male interlocking element 492, andback through female interlocking element 494. Lip lock 480 is configuredto maintain expansion of lip region 472, while skirt lock 490 isconfigured to maintain expansion of skirt region 474.

In FIG. 36B, anchor 470 is shown in the partially deployedconfiguration, e.g., after deployment from lumen 422 of sheath 420. Bodyregions 476, as well as lip region 472 and skirt region 474, self-expandto the partially deployed configuration. Full deployment is thenachieved by retracting wires 424 relative to anchor 470, and expandinglip region 472 and skirt region 474 outward, as seen in FIGS. 36C and36D. As seen in FIG. 36E, expansion continues until the male elementsengage the female interlocking elements of lip lock 480 and skirt lock490, thereby maintaining such expansion (lip lock 480 shown in FIG.36E). Advantageously, deployment of apparatus 450 is fully reversibleuntil lip lock 480 and/or skirt lock 490 has been actuated.

With reference to FIGS. 37A-B, isometric views, partially in section,further illustrate apparatus 450 in the fully deployed and expandedconfiguration. FIG. 37A illustrates the wire frame structure of anchor470, while FIG. 37B illustrates an embodiment of anchor 470 covered in abiocompatible material B. Placement of replacement valve 460 withinapparatus 450 may be seen in FIG. 37B. The patient's native valve iscaptured between lip region 472 and skirt region 474 of anchor 470 inthe fully deployed configuration (see FIG. 38B).

Referring to FIGS. 38A-C, in conjunction with FIGS. 35 and 36, a methodfor percutaneously replacing a patient's diseased aortic valve withapparatus 450 is described. Delivery system 410, having apparatus 450disposed therein, is percutaneously advanced, preferably in a retrogradefashion, through a patient's aorta A to the patient's diseased aorticvalve AV. Sheath 420 is positioned such that its distal end is disposedwithin left ventricle LV of the patient's heart H. As described withrespect to FIG. 35, apparatus 450 is deployed from lumen 422 of sheath420, for example, under fluoroscopic guidance, such that skirt section474 is disposed within left ventricle LV, body section 476 b is disposedacross the patient's native valve leaflets L, and lip section 472 isdisposed within the patient's aorta A. Advantageously, apparatus 450 maybe dynamically repositioned to obtain proper alignment with theanatomical landmarks. Furthermore, apparatus 450 may be retracted withinlumen 422 of sheath 420 via wires 424, even after anchor 470 hasdynamically expanded to the partially deployed configuration, forexample, to abort the procedure or to reposition sheath 420.

Once properly positioned, wires 424 a are retracted to expand skirtregion 474 of anchor 470 within left ventricle LV. Skirt region 474 islocked in the expanded configuration via skirt lock 490, as previouslydescribed with respect to FIG. 36. In FIG. 38A, skirt region 474 ismaneuvered such that it engages the patient's valve annulus An and/ornative valve leaflets L, thereby providing positive registration ofapparatus 450 relative to the anatomical landmarks.

Wires 424 b are then actuated external to the patient in order to expandlip region 472, as previously described in FIG. 35. Lip region 472 islocked in the expanded configuration via lip lock 480. Advantageously,deployment of apparatus 450 is fully reversible until lip lock 480and/or skirt lock 490 has been actuated. Wires 424 are pulled fromeyelets 483 and 493, and delivery system 410 is removed from thepatient. As will be apparent, the order of expansion of lip region 472and skirt region 474 may be reversed, concurrent, etc.

As seen in FIG. 38B, lip region 472 engages the patient's native valveleaflets L, thereby providing additional positive registration andreducing a risk of lip region 472 blocking the patient's coronary ostia0. FIG. 38C illustrates the same in cross-sectional view, while alsoshowing the position of replacement valve 460. The patient's nativeleaflets are engaged and/or captured between lip region 472 and skirtregion 474. Advantageously, lip region 472 precludes distal migration ofapparatus 450, while skirt region 474 precludes proximal migration. Itis expected that lip region 472 and skirt region 474 also will reduceparavalvular regurgitation.

With reference to FIGS. 39-41, a first embodiment of two-piece apparatusof the present invention adapted for percutaneous replacement of apatient's heart valve is described. As seen in FIG. 41, apparatus 510comprises a two-piece device having custom-designed expandable anchorpiece 550 of FIG. 39 and expandable replacement valve piece 600 of FIG.40. Both anchor piece 550 and valve piece 600 have reduced deliveryconfigurations and expanded deployed configurations. Both may be eitherballoon expandable (e.g. fabricated from a stainless steel) orself-expanding (e.g. fabricated from a nickel-titanium alloy (“Nitinol”)or from a wire mesh) from the delivery to the deployed configurations.

When replacing a patient's aortic valve, apparatus 510 preferably may bedelivered through the patient's aorta without requiring a transseptalapproach, thereby reducing patient trauma, complications and recoverytime. Furthermore, apparatus 510 enables dynamic repositioning of anchorpiece 550 during delivery and facilitates positive registration ofapparatus 510 relative to the native position of the patient's valve,thereby reducing a risk of device migration and reducing a risk ofblocking or impeding flow to the patient's coronary ostia. Furthermore,the expanded deployed configuration of apparatus 510, as seen in FIG.41D, is adapted to reduce paravalvular regurgitation, as well as tofacilitate proper seating of valve piece 600 within anchor piece 550.

As seen in FIG. 39, anchor piece 550 preferably comprises threesections. Lip section 560 is adapted to engage the patient's nativevalve leaflets to provide positive registration and ensure accurateplacement of the anchor relative to the patient's valve annulus duringdeployment, while allowing for dynamic repositioning of the anchorduring deployment. Lip section 560 also maintains proper positioning ofcomposite anchor/valve apparatus 510 post-deployment to preclude distalmigration. Lip section 560 optionally may be covered or coated withbiocompatible film B (see FIG. 41) to ensure engagement of the nativevalve leaflets. It is expected that covering lip section 560 with film Bespecially would be indicated when the native leaflets are stenosedand/or fused together

Groove section 570 of anchor piece 550 is adapted to engage anexpandable frame portion, described hereinbelow, of valve piece 600 tocouple anchor piece 550 to valve piece 600. As compared to previouslyknown apparatus, groove section 570 comprises additional material andreduced openings or gaps G, which is expected to reduce tissueprotrusion through the gaps upon deployment, thereby facilitating properseating of the valve within the anchor. Groove section 570 optionallymay be covered or coated with biocompatible film B (see FIG. 41) tofurther reduce native valve tissue protrusion through gaps G.

Finally, skirt section 580 of anchor piece 550 maintains properpositioning of composite anchor/valve apparatus 510 post-deployment byprecluding proximal migration. When replacing a patient's aortic valve,skirt section 580 is deployed within the patient's left ventricle. Aswith lip section 560 and groove section 570, skirt section 580optionally may be covered or coated with biocompatible film B (see FIG.41) to reduce paravalvular regurgitation. As will be apparent to thoseof skill in the art, all, a portion of, or none of anchor piece 50 maybe covered or coated with biocompatiple film B.

In FIG. 39A, a portion of anchor piece 550 has been flattened out toillustrate the basic anchor cell structure, as well as to illustratetechniques for manufacturing anchor piece 550. In order to form theentire anchor, anchor 550 would be bent at the locations indicated inFIG. 39A, and the basic anchor cell structure would be revolved to forma joined 360° structure. Lip section 560 would be bent back into thepage to form a lip that doubles over the groove section, groove section570 would be bent out of the page into a ‘C’- or ‘U’-shaped groove,while skirt section 580 would be bent back into the page. FIG. 39B showsthe anchor portion after bending and in an expanded deployedconfiguration.

The basic anchor cell structure seen in FIG. 39A is preferably formedthrough laser cutting of a flat sheet or of a hollow tube placed on amandrel. When formed from a flat sheet, the sheet would be cut to therequired number of anchor cells, bent to the proper shape, and revolvedto form a cylinder. The ends of the cylinder would then be joinedtogether, for example, by heat welding.

If balloon expandable, anchor piece 550 would be formed from anappropriate material, such as stainless steel, and then crimped onto aballoon delivery catheter in a collapsed delivery configuration. Ifself-expanding and formed from a shape-memory material, such as anickel-titanium alloy (“Nitinol”), the anchor piece would be heat-setsuch that it could be constrained within a sheath in the collapseddelivery configuration, and then would dynamically self-expand to theexpanded deployed configuration upon removal of the sheath. Likewise, ifanchor piece 550 were formed from a wire mesh or braid, such as a springsteel braid, the anchor would be constrained within a sheath in thedelivery configuration and dynamically expanded to the deployedconfiguration upon removal of the sheath.

In FIG. 40, valve piece 600 is described in greater detail. FIG. 40Aillustrates valve piece 600 in a collapsed delivery configuration, whileFIG. 40B illustrates the valve piece in an expanded deployedconfiguration. Valve piece 600 comprises replacement valve 610 coupledto expandable frame 620. Replacement valve 610 is preferably biologic,although synthetic valves may also be used. Replacement valve 610preferably comprises three leaflets 611 coupled to three posts 621 ofexpandable frame 620. Expandable frame 620 is preferably formed from acontinuous piece of material and may comprise tips 622 in the collapseddelivery configuration, which expand to form hoop 624 in the deployedconfiguration. Hoop 624 is adapted to engage groove section 570 ofanchor piece 550 for coupling anchor piece 550 to valve piece 600. Aswith anchor piece 550, valve piece 600 may be balloon expandable andcoupled to a balloon delivery catheter in the delivery configuration.Alternatively, anchor piece 550 may be self-expanding, e.g. Nitinol orwire mesh, and constrained within a sheath in the deliveryconfiguration.

Referring again to FIG. 41, a method for deploying valve piece 600 andcoupling it to deployed anchor piece 550 to form two-piece apparatus 510is described. In FIG. 41A, valve piece 600 is advanced within anchorpiece 550 in an at least partially compressed delivery configuration. InFIG. 41B, tips 622 of frame 620 are expanded such that they engagegroove section 570 of anchor piece 550. In FIG. 41C, frame 620 continuesto expand and form hoop 624. Hoop 624 flares out from the remainder ofvalve piece 600 and acts to properly locate the hoop within groovesection 570. FIG. 41D shows valve piece 600 in a fully deployedconfiguration, properly seated and friction locked within groove section570 to form composite anchor/valve apparatus 510.

Anchor piece 550 and valve piece 600 of apparatus 510 preferably arespaced apart and releasably coupled to a single delivery catheter whiledisposed in their reduced delivery configurations. Spacing the anchorand valve apart reduces a delivery profile of the device, therebyenabling delivery through a patient's aorta without requiring atransseptal approach. With reference to FIG. 42, a first embodiment ofsingle catheter delivery system 700 for use with apparatus 51 0 isdescribed. Delivery system 700 is adapted for use with a preferredself-expanding embodiment of apparatus 510.

Delivery system 700 comprises delivery catheter 710 having inner tube720, middle distal tube 730, and outer tube 740. Inner tube 720comprises lumen 722 adapted for advancement over a standard guide wire,per se known. Middle distal tube 730 is coaxially disposed about adistal region of inner tube 720 and is coupled to a distal end 724 ofthe inner tube, thereby forming proximally-oriented annular bore 732between inner tube 720 and middle tube 730 at a distal region ofdelivery catheter 710. Outer tube 740 is coaxially disposed about innertube-720 and extends from a proximal region of the inner tube to aposition at least partially coaxially overlapping middle distal tube730. Outer tube 740 preferably comprises distal step 742, wherein lumen743 of outer tube 740 is of increased diameter. Distal step 742 mayoverlap middle distal tube 730 and may also facilitate deployment ofvalve piece 600, as described hereinbelow with respect to FIG. 45.

Proximally-oriented annular bore 732 between inner tube 720 and middledistal tube 730 is adapted to receive skirt section 580 and groovesection 570 of anchor piece 550 in the reduced delivery configuration.Annular space 744 formed at the overlap between middle distal tube 730and outer tube 740 is adapted to receive lip section 560 of anchor piece550 in the reduced delivery configuration. More proximal annular space746 between inner tube 720 and outer tube 740 may be adapted to receivereplacement valve 610 and expandable frame 620 of valve piece 600 in thereduced delivery configuration.

Inner tube 720 optionally may comprise retainer elements 726 a and 726 bto reduce migration of valve piece 600. Retainer elements 726 preferablyare fabricated from a radiopaque material, such as platinum-iridium orgold, to facilitate deployment of valve piece 600, as well as couplingof the valve piece to anchor piece 550. Additional or alternativeradiopaque elements may be disposed at other locations about deliverysystem 700 or apparatus 510, for example, in the vicinity of anchorpiece 550.

With reference now to FIG. 43, an alternative delivery system for usewith apparatus of the present invention is described. Delivery system750 comprises two distinct catheters adapted to deliver the anchor andvalve pieces, respectively: anchor delivery catheter 710′ and valvedelivery catheter 760. In use, catheters 710′ and 760 may be advancedsequentially to a patient's diseased heart valve for sequentialdeployment and coupling of anchor piece 550 to valve piece 600 to formcomposite two-piece apparatus 510.

Delivery catheter 710′ is substantially equivalent to catheter 710described hereinabove, except that catheter 710′ does not compriseretainer elements 726, and annular space 746 does not receive valvepiece 600. Rather, valve piece 600 is received within catheter 760 inthe collapsed delivery configuration. Catheter 760 comprises inner tube770 and outer tube 780. Inner tube 770 comprises lumen 772 foradvancement of catheter 760 over a guide wire. The inner tube optionallymay also comprise retainer elements 774 a and 774 b, e.g. radiopaqueretainer elements 774, to reduce migration of valve piece 600. Outertube 780 is coaxially disposed about inner tuber 770 and preferablycomprises distal step 782 to facilitate deployment and coupling of valvepiece 600 to anchor piece 550, as described hereinbelow. Valve piece 600may be received in annular space 776 between inner tube 770 and outertube 780, and more preferably may be received within annular space 776between retainer elements 774.

Referring now to FIG. 44, another alternative delivery system isdescribed. As discussed previously, either anchor piece 550 or valvepiece 600 (or portions thereof or both) may be balloon expandable fromthe delivery configuration to the deployed configuration. Deliverysystem 800 is adapted for delivery of an embodiment of apparatus 510wherein the valve piece is balloon expandable. Additional deliverysystems—both single and multi-catheter—for deployment of alternativecombinations of balloon and self-expandable elements of apparatus of thepresent invention will be apparent to those of skill in the art in viewof the illustrative delivery systems provided in FIGS. 42-44.

In FIG. 44, delivery system 800 comprises delivery catheter 710″.Delivery catheter 710″ is substantially equivalent to delivery catheter710 of delivery system 700, except that catheter 710″ does not compriseretainer elements 726, and annular space 746 does not receive the valvepiece. Additionally, catheter 710″ comprises inflatable balloon 802coupled to the exterior of outer tube 740″, as well as an inflationlumen (not shown) for reversibly delivering an inflation medium from aproximal region of catheter 710″ into the interior of inflatable balloon802 for expanding the balloon from a delivery configuration to adeployed configuration. Valve piece 600 may be crimped to the exteriorof balloon 802 in the delivery configuration, then deployed and coupledto anchor piece 550 in vivo. Delivery catheter 710″ preferably comprisesradiopaque marker bands 804 a and 804 b disposed on either side ofballoon 802 to facilitate proper positioning of valve piece 600 duringdeployment of the valve piece, for example, under fluoroscopic guidance.

With reference now to FIG. 45, in conjunction with FIGS. 39-42, anillustrative method of percutaneously replacing a patient's diseasedheart valve using apparatus of the present invention is described. InFIG. 45A, a distal region of delivery system 700 of FIG. 42 has beendelivered through a patient's aorta A, e.g., over a guide wire and underfluoroscopic guidance using well-known percutaneous techniques, to avicinity of diseased aortic valve AV of heart H. Apparatus 510 of FIGS.39-41 is disposed in the collapsed delivery configuration withindelivery catheter 710 with groove section 570 and skirt section 580 ofanchor piece 550 collapsed within annular bore 732, and lip section 560of anchor piece 550 collapsed within annular space 744. Valve piece 600is disposed in the collapsed delivery configuration between retainerelements 726 within more proximal annular space 746. Separation ofanchor piece 550 and valve piece 600 of apparatus 510 along thelongitudinal axis of delivery catheter 710 enables percutaneous aorticdelivery of apparatus 510 without requiring a transseptal approach.

Aortic valve AV comprises native valve leaflets L attached to valveannulus An. Coronary ostia O are disposed just proximal of diseasedaortic valve AV. Coronary ostia O connect the patient's coronaryarteries to aorta A and are the conduits through which the patient'sheart muscle receives oxygenated blood. As such, it is critical that theostia remain unobstructed post-deployment of apparatus 510.

In FIG. 45A, a distal end of delivery catheter 710 has been deliveredacross diseased aortic valve AV into the patient's left ventricle LV. Asseen in FIG. 45B, outer tube 740 is then retracted proximally relativeto inner tube 720 and middle distal tube 730. Outer tube 740 no longercoaxially overlaps middle distal tube 730, and lip section 560 of anchorpiece 550 is removed from annular space 744. Lip section 560self-expands to the deployed configuration. As seen in FIG. 45C, innertube 720 and middle tube 730 (or all of delivery catheter 710) are thendistally advanced until lip section 560 engages the patient's nativevalve leaflets L, thereby providing positive registration of anchorpiece 550 to leaflets L. Registration may be confirmed, for example, viafluoroscopic imaging of radiopaque features coupled to apparatus 510 ordelivery system 700 and/or via resistance encountered by the medicalpractitioner distally advancing anchor piece 550.

Lip section 560 may be dynamically repositioned until it properlyengages the valve leaflets, thereby ensuring proper positioning ofanchor piece 550 relative to the native coronary ostia 0, as well as thevalve annulus An, prior to deployment of groove section 570 and skirtsection 580. Such multi-step deployment of anchor piece 550 enablespositive registration and dynamic repositioning of the anchor piece.This is in contrast to previously known percutaneous valve replacementapparatus.

As seen in FIG. 45D, once leaflets L have been engaged by lip section560 of anchor piece 550, inner tube 720 and middle distal tube 730 arefurther distally advanced within left ventricle LV, while outer tube 740remains substantially stationary. Lip section 560, engaged by leafletsL, precludes further distal advancement/migration of anchor piece 550.As such, groove section 570 and skirt section 580 are pulled out ofproximally-oriented annular bore 732 between inner tube 720 and middledistal tube 730 when the tubes are distally advanced. The groove andskirt sections self-expand to the deployed configuration, as seen inFIG. 45E. Groove section 570 pushes native valve leaflets L and lipsection 560 against valve annulus An, while skirt section 580 sealsagainst an interior wall of left ventricle LV, thereby reducingparavalvular regurgitation across aortic valve AV and precludingproximal migration of anchor piece 550.

With anchor piece 550 deployed and native aortic valve AV displaced,valve piece 600 may be deployed and coupled to the anchor piece toachieve percutaneous aortic valve replacement. Outer tube 740 is furtherproximally retracted relative to inner tube 720 such that valve piece600 is partially deployed from annular space 746 between inner tube 720and outer tube 740, as seen in FIG. 45F. Expandable frame 620 coupled toreplacement valve 610 partially self-expands such that tips 622partially form hoop 624 for engagement of groove section 570 of anchorpiece 550 (see FIG. 41B). A proximal end of expandable frame 620 isengaged by distal step 742 of outer tube 740.

Subsequent re-advancement of outer tube 740 relative to inner tube 720causes distal step 742 to distally advance valve piece 600 within anchorpiece 550 until tips 622 of expandable frame 620 engage groove section570 of anchor piece 550, as seen in FIG. 450. As discussed previously,groove section 570 comprises additional material and reduced openings orgaps G, as compared to previously known apparatus, which is expected toreduce native valve tissue protrusion through the gaps and facilitateengagement of tips 622 with the groove section. Outer tube 740 then isproximally retracted again relative to inner tube 720, and valve piece600 is completely freed from annular space 746. Frame 620 of valve piece600 fully expands to form hoop 624, as seen in FIG. 45H.

Hoop 624 friction locks within groove section 570 of anchor piece 550,thereby coupling the anchor piece to the valve piece and formingcomposite two-piece apparatus 510, which provides a percutaneous valvereplacement. As seen in FIG. 451, delivery catheter 710 may then beremoved from the patient, completing the procedure. Blood may freelyflow from left ventricle LV through replacement valve 610 into aorta A.Coronary ostia 0 are unobstructed, and paravalvular regurgitation isreduced by skirt section 580 of anchor piece 550.

Referring now to FIG. 46, an alternative embodiment of two-pieceapparatus 510 is described comprising an alignment/locking mechanism.Such a mechanism may be provided in order to ensure proper radialalignment of the expandable frame of the valve piece with the groovesection of the anchor piece, as well as to ensure proper longitudinalpositioning of the frame within the hoop. Additionally, thealignment/locking mechanism may provide a secondary lock to furtherreduce a risk of the anchor piece and the valve piece becoming separatedpost-deployment and coupling of the two pieces to achieve percutaneousvalve replacement.

In FIG. 46, apparatus 510′ comprises valve piece 600′ of FIG. 46A andanchor piece 550′ of FIG. 46B. Anchor piece 550′ and valve piece 600′are substantially the same as anchor piece 550 and valve piece 600described hereinabove, except that anchor piece 550′ comprises firstportion 652 of illustrative alignment/locking mechanism 650, while valvepiece 600′ comprises second portion 654 of the alignment/lockingmechanism for coupling to the first portion. First portion 652illustratively comprises three guideposts 653 coupled to skirt section580′ of anchor piece 550′ (only one guidepost shown in the partial viewof FIG. 46B), while second portion 654 comprises three sleeves 655coupled to posts 621′ of expandable frame 620′ of valve piece 600′.

When anchor piece 550′ is self-expanding and collapsed in the deliveryconfiguration, guideposts 653 may be deployed with skirt section 580′,in which case guideposts 653 would rotate upward with respect to anchorpiece 550′ into the deployed configuration of FIG. 46B. Alternatively,when anchor piece 550′ is either balloon or self-expanding and iscollapsed in the delivery configuration, guideposts 653 may be collapsedagainst groove section 570′ of the anchor piece and may be deployed withthe groove section. Deploying guideposts 653 with skirt section 580′ hasthe advantages of reduced delivery profile and ease of manufacturing,but has the disadvantage of significant dynamic motion duringdeployment. Conversely, deploying guideposts 653 with groove section570′ has the advantage of minimal dynamic motion during deployment, buthas the disadvantage of increased delivery profile. Additionaldeployment configurations will be apparent to those of skill in the art.As will also be apparent, first portion 652 of alignment/lockingmechanism 650 may be coupled to alternative sections of anchor piece550′ other than skirt section 580′.

Sleeves 655 of second portion 654 of alignment/locking mechanism 650comprise lumens 656 sized for coaxial disposal of sleeves 655 aboutguideposts 653 of first portion 652. Upon deployment, sleeves 655 mayfriction lock to guideposts 653 to ensure proper radial and longitudinalalignment of anchor piece 550′ with valve piece 600′, as well as toprovide a secondary lock of the anchor piece to the valve piece. Thesecondary lock enhances the primary friction lock formed by groovesection 570′ of the anchor piece with hoop 624′ of expandable frame 620′of the valve piece.

To facilitate coupling of the anchor piece to the valve piece, suture orthread may pass from optional eyelets 651 a of guideposts 653 throughlumens 656 of sleeves 655 to a proximal end of the delivery catheter(see FIG. 47). In this manner, second portion 654 of mechanism 650 maybe urged into alignment with first portion 652, and optional suture knot(not shown), e.g. pre-tied suture knots, may be advanced on top of themechanism post-coupling of the two portions to lock the two portionstogether. Alternatively, guideposts 653 may comprise optional one-wayvalves 651 b to facilitate coupling of the first portion to the secondportion. Specifically, sleeves 655 may be adapted for coaxialadvancement over one-way valves 651 b in a first direction that couplesthe sleeves to guideposts 653, but not in a reverse direction that woulduncouple the sleeves from the guideposts.

Referring now to FIG. 47, an alternative embodiment of apparatus 510′comprising an alternative alignment/locking mechanism is described.Apparatus 510″ is illustratively shown in conjunction with deliverysystem 700 described hereinabove with respect to FIG. 42. Valve piece600″ is shown partially deployed from outer tube 740 of catheter 710.For the sake of illustration, replacement valve 610″ of valve piece600″, as well as inner tube 720 and middle distal tube 730 of deliverycatheter 710, are not shown in FIG. 47.

In FIG. 47, anchor piece 550″ of apparatus 510″ comprises first portion652′ of alignment/locking mechanism 650′, while valve piece 600″comprises second portion 654′ of the alternative alignment/lockingmechanism. First portion 652′ comprises eyelets 660 coupled to groovesection 570″ of anchor piece 550″. Second portion 654′ comprises knottedloops of suture 662 coupled to tips 622″ of expandable frame 620″ ofvalve piece 600″. Suture 661 extends from knotted loops of suture 662through eyelets 660 and out through annular space 746 between outer‘tube 7 40 and inner tube 720 (see FIG. 42) of catheter 710 to aproximal end of delivery system 700. In this manner, a medicalpractitioner may radially and longitudinally align valve piece 600″ withanchor piece 550″ by proximally retracting sutures 661 (as shown byarrows in FIG. 47) while distally advancing distal step 742 of outertube 740 against valve piece 600″ until tips 622″ of the valve pieceengage groove section 570″ of anchor piece 550″. Proximal retraction ofouter tube 740 then causes expandable frame 620″ to further expand andform hoop 624″ that friction locks with groove section 570″ of anchorpiece 550″, thereby forming apparatus 51 0″ as described hereinabovewith respect to apparatus 510. A secondary lock may be achieved byadvancing optional suture knots (not shown) to the overlap of eyelets660 and knotted loops of suture 662. Such optional suture knotspreferably are pre-tied.

With reference now to FIG. 48, yet another alternative embodiment ofapparatus 510′, comprising yet another alternative alignment/lockingmechanism 650, is described. First portion 652″ of alignment/lockingmechanism 650″ is coupled to anchor piece 550″′ of apparatus 510″′,while second portion 654″ is coupled to valve piece 600″′. The firstportion comprises male posts 670 having flared ends 671, while thesecond portion comprises female guides 672 coupled to tips 622″′ ofexpandable frame 620′″ of valve piece 600″′.

Female guides 672 are translatable about male posts 670, but areconstrained by flared ends 671 of the male posts. In this manner, anchorpiece 550″′ and valve piece 600″′ remain coupled and in radial alignmentwith one another at all times—including delivery—but may belongitudinally separated from one another during delivery. Thisfacilitates percutaneous delivery without requiring a transseptalapproach, while mitigating a risk of inadvertent deployment of theanchor and valve pieces in an uncoupled configuration. Additionalalignment/locking mechanisms will be apparent in view of the mechanismsdescribed with respect to FIGS. 46-48.

Prior to implantation of one of the replacement valves described above,it may be desirable to perform a valvoplasty on the diseased valve byinserting a balloon into the valve and expanding it using saline mixedwith a contrast agent. In addition to preparing the valve site forimplant, fluoroscopic viewing of the valvoplasty will help determine theappropriate size of replacement valve implant to use.

What is claimed is:
 1. A replacement heart valve assembly comprising: anexpandable anchor having a delivery configuration and a fully deployedconfiguration, the expandable anchor comprising a skirt region, a lipregion, and a groove region therebetween; in the delivery configuration,the expandable anchor having a first diameter and a first length and inthe fully deployed configuration having a second diameter and a secondlength, wherein the first length is greater than the second length andthe second diameter is greater than the first diameter; a replacementvalve disposed within the expandable anchor, the replacement valveincluding posts and hoop regions, the posts and hoop regions having acollapsed delivery configuration and an expanded deployed configurationin which the hoop regions are adapted to engage the groove region of theexpandable anchor in the fully deployed configuration thereof; the lipregion of the expandable anchor is configured and adapted to expandradially outward relative to the groove region while transitioning fromthe delivery configuration to the fully deployed configuration to engagenative valve leaflets and to provide positive registration and ensureaccurate placement of the expandable anchor relative to a valve annulusduring deployment.
 2. The replacement heart valve assembly of claim 1,wherein the posts and hoop regions form an expandable frame.
 3. Thereplacement heart valve assembly of claim 2, wherein the expandableframe is formed from a continuous piece of material.
 4. The replacementheart valve assembly of claim 3, wherein the continuous piece ofmaterial is balloon expandable.
 5. The replacement heart valve assemblyof claim 3, wherein the continuous piece of material is self-expanding.6. The replacement heart valve assembly of claim 5, wherein theexpandable anchor is balloon expandable.
 7. The replacement heart valveassembly of claim 1, wherein the expandable anchor is a self-expandingexpandable anchor.
 8. The replacement heart valve assembly of claim 7,wherein the self-expanding expandable anchor is Nitinol.
 9. Thereplacement heart valve assembly of claim 1, wherein a valve portion ofthe replacement heart valve assembly comprises a plurality of leaflets.10. The replacement heart valve assembly of claim 9, wherein the valveportion of the replacement heart valve assembly comprises threeleaflets.
 11. The replacement heart valve assembly of claim 9, whereinthe plurality of leaflets comprise a synthetic material.
 12. Thereplacement heart valve assembly of claim 9, wherein the plurality ofleaflets comprise biologic tissue.
 13. The replacement heart valveassembly of claim 12, wherein the biologic tissue is porcine tissue. 14.The replacement heart valve assembly of claim 12, wherein the biologictissue is bovine tissue.
 15. The replacement heart valve assembly ofclaim 10, wherein in cross-section, the groove region has a concaveinner surface and a convex outer surface.
 16. The replacement heartvalve assembly of claim 15, wherein the groove region is C-shaped incross-section.
 17. The replacement heart valve assembly of claim 15,wherein the groove region is U-shaped in cross-section.
 18. Thereplacement heart valve assembly of claim 1, wherein the skirt region ofthe expandable anchor is located at an in-flow end of the replacementheart valve assembly.
 19. The replacement heart valve assembly of claim15, wherein an outer surface of the skirt region faces toward the grooveregion in the fully deployed configuration.